Remote Senior Manager, Clinical Operations & Strategy

Lycia Therapeutics, Inc.; South San Francisco (CA); On-site; USD 169,000 - 250,000; Full time

Job summary

Lycia Therapeutics, Inc. is seeking an experienced Clinical Operations leader to create and execute strategic plans for clinical programs, aligning resources with product strategy and ensuring timely delivery.

You will oversee outsourcing, vendor relationships, budgeting, SOPs and regulatory compliance (FDA/ICH-GCP), build a high‑performing team, and travel as needed for trials; this remote role offers flexibility while collaborating with our South San Francisco HQ.

Qualifications

• Bachelor's degree required; advanced degrees preferred.
• Minimum 7 years in clinical operations for manager, 12+ years for director.
• Strong leadership, collaboration, and strategic thinking.
• Ability to influence across functions in a global setting.

Responsibilities

• Create and execute clinical operational strategic plans aligned with product strategy and resources.
• Develop study feasibility, cost estimates, and support outsourcing contracts and changes.
• Track study finances, accruals, and vendor invoices.
• Build and train internal staff and external vendors to improve efficiency.
• Develop and ensure SOPs, FDA regulations and ICH-GCP compliance.
• Oversee CROs, vendors, and investigative sites.
• Participate in clinical operations and study team meetings.
• Maintain up-to-date knowledge of clinical literature and regulatory practice.

Skills

Clinical operations leadership

Budgeting & forecasting

Vendor management

Cross-functional collaboration

Regulatory compliance (FDA/ICH-GCP)

Education

B.A./B.S. required

MS/PhD/PharmD/MD strongly preferred

Job description

Lycia Therapeutics, Inc. is seeking an experienced Clinical Operations leader to create and execute strategic plans for clinical programs, aligning resources with product strategy and ensuring timely delivery.

You will oversee outsourcing, vendor relationships, budgeting, SOPs and regulatory compliance (FDA/ICH-GCP), build a high‑performing team, and travel as needed for trials; this remote role offers flexibility while collaborating with our South San Francisco HQ.